Anti-inflammatory Dietary Intervention in Overweight and Obese Adolescents (NCT01665742) | Clinical Trial Compass
CompletedNot Applicable
Anti-inflammatory Dietary Intervention in Overweight and Obese Adolescents
Ireland58 participantsStarted 2012-01
Plain-language summary
The number of overweight and obese children has increased in Ireland at a greater rate than worldwide trends. The poor eating patterns that drive adolescent obesity leads to an increase in the number of unhealthy inflammatory hormones and fats circulating in the blood which increase an adolescent's risk of developing diabetes and heart disease later in life. Dietary patterns have changed whereby key nutrients that are found in fruit, vegetables and fish, which are known to have beneficial effects and reduce risk of obesity and diabetes in later life, may need to be replaced. This project will determine whether a key anti-inflammatory nutrient supplement taken for 8 weeks will improve the metabolic profile of adolescents aged 13-18 years old. Detailed cellular analysis will determine the cellular and molecular mechanisms to provide a thorough explanation of the health effects of this intervention.
Who can participate
Age range
13 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female
. 13-18 years
. Body mass index ≥ 91st percentile on UK growth reference charts (Cole, 1995)
. Medications/dietary supplements which do not interfere with the intervention are allowed, on condition that the participants adhere to the same regimen during the intervention, including oral contraceptives and other non-fatty acid based dietary supplements (e.g. garlic)
. Smoker or non-smoker
. Not participating in any other intervention study
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Homeostasis model of assessment - insulin resistance